The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
340B Drug Pricing Program Compliance
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
Drug Pricing Initiatives During the Trump Presidency
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
The Federal Trade Commission (FTC) has launched an inquiry into the largest Pharmacy Benefit Managers (PBMs) in the United States, with the goal of scrutinizing the PBMs’ practices and influence on the pharmaceutical...more
Although President Trump has made California a favored object of scorn, the Golden State has put itself on a path to help patients better rein in Big Pharma price gouging on prescription drugs in a way that Washington hasn’t....more
On July 25, 2019 the Senate Finance Committee voted to advance their long-awaited drug pricing package to the Senate floor (we anticipate a Floor vote sometime this Fall). The Prescription Drug Pricing Reduction Act (PDPRA)...more
Food/Dietary Supplements - FDA Announces Guidance on Added Sugar Labeling – The FDA published a new guidance for labeling of added sugars. ...more
To paraphrase what a one-time colleague once wrote about her bosses: Never trust Big Pharma, never trust Big Pharma, never trust Big Pharma. Here’s some of the latest evidence why: Even the industry’s so-called “white hats,”...more
Notwithstanding the enactment of a first-in-the-nation drug spending cap last year, in light of the $4.4 billion deficit and ongoing concerns about the opioid crisis it was inevitable that this year New York State would once...more
Some big hospitals and hospital chains are on the brink of expanding into another aspect of health care. Let’s give them a rare cheer, because they’re taking on Big Pharma and its skyrocketing drug prices and too frequent...more
On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more
On September 28, 2016, the Third Circuit issued an opinion in Mylan v. Warner Chilcott, upholding the Eastern District of Pennsylvania’s holding on summary judgement that Defendants’ “product hopping” conduct did not violate...more
Since 2014, drug pricing has grown in importance in health care policy conversations. From Gilead Sciences’s Hepatitis C treatment costing $84,000 per course of treatment to Turing Pharmaceutical’s 5,000 percent price hike of...more
On Thursday, January 21, the Centers for Medicare & Medicaid Services (CMS or “the Agency”) published its long-awaited final rule with comment period implementing the Medicaid pricing and reimbursement provisions of the...more
The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Horizon Pharma, Inc. et al. v. Actavis Laboratories FL., Inc. et al. 3:15-cv-03322; filed May 13, 2015 in the District...more
Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more
On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more